Axsome Says FDA Acknowledges Resubmission Of NDA For AXS-07 For Migraine

(RTTNews) - Axsome Therapeutics, Inc. (AXSM) announced on Wednesday that the FDA has accepted the resubmission of its New Drug Application or NDA, for AXS-07, a treatment designed for acute migraines.

The FDA has designated this as a Class 2 resubmission and has set a target action date of January 31, 2025, under the Prescription Drug User Fee Act.

AXS-07 is an oral medication that absorbs quickly and uses multiple mechanisms to treat migraine attacks, combining MoSEIC meloxicam with rizatriptan.

In pre-market activity on the Nasdaq, the shares are trading at $89.66, up 0.01%.